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Fenofibrate Micronised

Fenofibrate Micronised, a medication primarily used to lower cholesterol and triglyceride levels, is being studied in various clinical trials for its potential benefits in treating different medical conditions. These trials aim to explore the drug’s effectiveness, safety, and possible new applications beyond its current approved uses. The studies cover a range of health issues, including diabetic nephropathy, primary biliary cholangitis, and severe hypertriglyceridemia during pregnancy.

Table of Contents

What is Fenofibrate?

Fenofibrate is a medication primarily used to treat high cholesterol and high triglyceride levels in the blood. It belongs to a class of drugs called fibrates. The micronised form of fenofibrate refers to a special preparation where the drug particles are made extremely small, which can improve how well the body absorbs the medication[1].

Fenofibrate is known by several brand names, including:

  • Antara
  • Fenoglide
  • Fibricor
  • Lipofen
  • Lofibra
  • TriCor

These different names represent various formulations of the same active ingredient[2].

Conditions Treated with Fenofibrate

Fenofibrate is primarily used to treat the following conditions:

  1. Dyslipidemia: This is a condition where there are abnormal levels of lipids (fats) in the blood. Fenofibrate helps reduce triglycerides and increase “good” cholesterol (HDL)[1].
  2. Severe Hypertriglyceridemia: This refers to very high levels of triglycerides in the blood, which can increase the risk of pancreatitis (inflammation of the pancreas)[3].
  3. Diabetic Retinopathy: Fenofibrate is also used to slow the progression of eye problems in patients with type 2 diabetes[4].

Ongoing research is exploring the potential use of fenofibrate in other conditions, such as:

  • Primary Biliary Cholangitis (PBC): A chronic liver disease where fenofibrate may help improve liver function when combined with other treatments[5].
  • Diabetic Nephropathy: A kidney condition associated with diabetes where fenofibrate might help protect kidney function[4].
  • Multiple Myeloma: A type of blood cancer where fenofibrate is being studied for its potential anti-cancer effects[6].

How Fenofibrate Works

Fenofibrate works in several ways to improve lipid levels in the body:

  1. It reduces the production of triglycerides in the liver.
  2. It increases the breakdown of fatty acids.
  3. It enhances the removal of LDL cholesterol (often called “bad” cholesterol) from the bloodstream.
  4. It increases the production of HDL cholesterol (often called “good” cholesterol)[1].

In addition to its effects on lipids, fenofibrate may have anti-inflammatory properties and could affect how the body uses glucose (sugar), which might explain its potential benefits in conditions like diabetic retinopathy and nephropathy[4].

Dosage and Administration

Fenofibrate is typically taken orally (by mouth) once daily. The dosage can vary depending on the specific condition being treated and the individual patient’s characteristics. Some common dosages include:

  • 145 mg or 160 mg once daily for general lipid control[1]
  • 200 mg once daily for severe hypertriglyceridemia or in combination with other medications for liver conditions[5]

It’s important to note that the dosage may need to be adjusted for patients with kidney problems. For example, patients with poor kidney function might receive a lower dose of 54 mg or 100 mg daily[6][4].

Fenofibrate is usually taken with food to improve its absorption. Always follow your doctor’s instructions regarding dosage and administration.

Potential Side Effects

Like all medications, fenofibrate can cause side effects. Common side effects may include:

  • Stomach pain or nausea
  • Headache
  • Back pain
  • Abnormal liver function tests

More serious but less common side effects can include muscle pain or weakness, which could be a sign of a rare but serious condition called rhabdomyolysis. If you experience unexplained muscle pain, tenderness, or weakness, especially if accompanied by fever or dark-colored urine, contact your doctor immediately[4].

Ongoing Research and Potential New Uses

Researchers are continually studying fenofibrate to understand its full potential. Some areas of ongoing research include:

  1. Pregnancy and Severe Hypertriglyceridemia: A study is investigating the safety of using fenofibrate during pregnancy when triglyceride levels are dangerously high[3].
  2. Primary Biliary Cholangitis (PBC): Several studies are looking at combining fenofibrate with other treatments to improve outcomes in this liver disease[5][7].
  3. Diabetic Complications: Research is exploring how fenofibrate might help protect against kidney and eye complications in diabetes[4].
  4. Cancer Treatment: Early research is investigating whether fenofibrate could have a role in treating certain types of cancer, such as multiple myeloma[6].
  5. Weight Management: Some studies are looking at whether fenofibrate, when combined with other medications, could help with weight loss in obese patients[8].

These ongoing studies highlight the potential versatility of fenofibrate and may lead to new approved uses in the future. However, it’s important to remember that fenofibrate should only be used as prescribed by a healthcare professional for approved indications.

Aspect Details
Conditions Studied Severe hypertriglyceridemia during pregnancy, diabetic nephropathy, primary biliary cholangitis, dyslipidemia, obesity
Key Objectives Evaluate safety and efficacy, assess effects on pregnancy outcomes, explore genetic factors in drug response, investigate metabolic changes
Dosage Forms Oral tablets or capsules, typically 100-300 mg daily, adjusted based on kidney function in some studies
Combination Therapies Often studied in combination with ursodeoxycholic acid (UDCA) for liver conditions, metformin for obesity
Study Durations Range from 30 days to long-term studies up to 120 months
Primary Outcomes Changes in lipid profiles, liver enzyme levels, metabolic markers, adverse events
Secondary Outcomes Effects on retinopathy, changes in body weight, waist circumference, placental transfer of the drug
Special Populations Pregnant women, patients with genetic variations affecting drug metabolism

FAQ

  • What is Fenofibrate Micronised used for in these clinical trials? Fenofibrate Micronised is being studied for various conditions, including severe hypertriglyceridemia during pregnancy, diabetic nephropathy, primary biliary cholangitis, and dyslipidemia. Researchers are exploring its potential benefits beyond its primary use of lowering cholesterol and triglycerides.
  • Are there any studies looking at Fenofibrate's use during pregnancy? Yes, there is a study (NCT05883865) evaluating the safety and efficacy of Fenofibrate in treating pregnant women with severe hypertriglyceridemia. The study aims to assess its effects on pregnancy outcomes and infant growth.
  • How is Fenofibrate being studied in relation to genetic factors? One study (NCT00613613) is investigating whether genetics plays a role in predicting a person's response to Fenofibrate. This research focuses on how genes affecting drug metabolism and drug targets influence the medication's effectiveness in lowering lipids.
  • Is Fenofibrate being studied for kidney-related conditions? Yes, a study (NCT03869931) is exploring the effects of Fenofibrate on diabetic nephropathy, a kidney condition associated with diabetes. The research aims to understand how Fenofibrate might affect fuel metabolism in patients with this condition.
  • Are there any long-term studies on Fenofibrate's use? Several long-term studies are underway, including ones for primary biliary cholangitis (PBC). These studies, such as NCT06755151 and NCT06365424, aim to evaluate the safety, tolerability, and effectiveness of Fenofibrate in combination with other treatments for PBC over extended periods, up to 120 months.

Ongoing Clinical Trials on Fenofibrate Micronised

  • Evaluation of fenofibrate treatment on beta cell function in children and adolescents newly diagnosed with type 1 diabetes

    Not recruiting

    1 1
    Investigated drugs:
    Poland

Glossary

  • Hypertriglyceridemia: A condition characterized by high levels of triglycerides (a type of fat) in the blood, which can increase the risk of health problems such as pancreatitis.
  • Diabetic Nephropathy: A kidney-related complication of diabetes that can lead to kidney damage and potentially end-stage renal disease.
  • Primary Biliary Cholangitis (PBC): A chronic liver disease that slowly destroys the bile ducts in the liver, potentially leading to liver damage and cirrhosis.
  • Dyslipidemia: An abnormal amount of lipids (e.g., cholesterol and/or fat) in the blood, which can increase the risk of cardiovascular diseases.
  • Pharmacogenetics: The study of how genes affect a person's response to drugs, aiming to develop safe and effective medications tailored to a person's genetic makeup.
  • Ursodeoxycholic Acid (UDCA): A medication used to treat certain types of liver diseases, often used in combination with Fenofibrate in some clinical trials.
  • Alkaline Phosphatase (ALP): An enzyme found in several tissues throughout the body. In clinical trials, ALP levels are often measured to assess liver function and treatment effectiveness.
  • Metabolomics: The scientific study of chemical processes involving metabolites, which are small molecule intermediates and products of metabolism.
  • Acyl-carnitines: Compounds formed from carnitine and acyl-CoA molecules, which play a crucial role in the transport of fatty acids into mitochondria for energy production.
  • Optical Coherence Tomography (OCT): A non-invasive imaging technique used to obtain high-resolution cross-sectional images of the retina, often used in studies involving diabetic retinopathy.

References

  1. https://clinicaltrials.gov/study/NCT00613613
  2. https://clinicaltrials.gov/study/NCT02965911
  3. https://clinicaltrials.gov/study/NCT05883865
  4. https://clinicaltrials.gov/study/NCT03869931
  5. https://clinicaltrials.gov/study/NCT02823353
  6. https://clinicaltrials.gov/study/NCT01965834
  7. https://clinicaltrials.gov/study/NCT06365424
  8. https://clinicaltrials.gov/study/NCT00349635